"Vibwife One" a New Medical Device to Support Delivering Women in Their Mobilization

NCT03443349 | Completed DMC

• 1 other identifier: 2017-02085
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

"Vibwife One" was developed to support the mobilization of the delivering women during the labor process. It consists of a mattress that fits on existing delivery beds. Different movements, adjustable in pace and intensity can be chosen to mobilize women in labor. Although existing evidence is rare, some literature and historical reports have shown a positive impact of active mobilization during labor. At time of rising epidural anesthesia rate, "Vibwife One" could be an interesting way to active mobilize those women to support the physiological birth process. So far, the device has not yet been applied in delivering women. The investigators carry out a first safety study to assess the safety, to evaluate the comfort and the practicability for delivering women and medical staff of this new medical device.

Conditions

Medical Device

Keywords

Delivering Women

Outcome Measures

Primary Outcomes (1)

• Safety measured by number of Adverse Events and Adverse Device Effects

  The Primary outcome is safety of the pregnant woman and the child using "Vibwife One" in the first stage of Labor. It will be evaluated according to predefined Adverse Events and Adverse Device Effects.

  During intervention and until 30min. after end of intervention

Secondary Outcomes (3)

• Pain intensity

  VAS before, during and after end of the intervention, intervention lasting up to 30 min.

• Preferences measured by questionnaire

  within 30 minutes after end of the intervention, intervention lasting up to 30 min.

• Practicability measured by questionnaire

  from first birth in the study until last birth in the study (start of study until study completion an average of 1 year)

Other Outcomes (3)

• Duration of first stage of labor measured by hours

  assessed during birth

• Duration of second stage of labor measured by hours

  assessed during birth

• Delivery Outcome measured by frequency of route of delivery

  from first birth in the study until last birth in the study (start of study until study completion an average of 1 year)

Study Arms (1)

Use of the medical Device: Vibwife One

OTHER

The medical device will be used according to its market authorization. Because it will be used for the first time in pregnant women, the following three step application procedure has been determined: * First five pregnant women use the device for 10 minutes. Each of them in a position and module proposed by the midwife with the agreement of the woman. * Next 10 pregnant women use the device for 20 minutes. Again, position and module according to the decision of the midwife with the agreement of the woman. * All the remaining pregnant women (35) use the device for 30 minutes. Position and module according to the decision of the midwife with the agreement of the woman. During the intervention period, position and module might be changed once if required.

Device: Vibwife One

Interventions

Vibwife One DEVICE

Vibwife One is a powered rotation bed intended to be used to assist in active mobilization of delivering women. "Vibwife One" imitates manual mobilization and position techniques. It is integrated in the mattress and fixed to the pelvis area of the birthing bed. "Vibwife One" can be used, when manual mobilization and position techniques are deemed appropriate. The device with all its functions is controlled over a remote control.

Use of the medical Device: Vibwife One

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent documented by signature
• German or English speaking
• Singleton healthy pregnancy
• Cephalic presentation
• ≥37th weeks of gestation
• cm - 9cm of dilatation
• Regular contractions
• Physiological cardiotocograph (CTG) 30 min pre-intervention
• Physiological blood pressure (111/66 - 139/89)

You may not qualify if:

• Multiple pregnancies
• Breech position
• Small for gestational age (\<10. Percentile)
• Fetal congenital abnormalities
• Placenta praevia
• Fetal distress
• Heavy vaginal bleeding during birth
• Maternal weight ≥ 135 kg
• Preeclampsia or HELLP
• Diabetes I and II / Gestational diabetes insulin dependent
• Spinal and back disorder (herniated disk / scoliosis)
• Hypertension (≥140/90 mmHg)
• Hypotension (Basic blood pressure in the third trimester -20%, if not available: ≤ 110/65 mmHg)
• No signed informed consent

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Clinical Trial Unit, University Hospital Basel, Switzerland: collaborator

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (2)

• Lawrence A, Lewis L, Hofmeyr GJ, Styles C. Maternal positions and mobility during first stage labour. Cochrane Database Syst Rev. 2013 Aug 20;(8):CD003934. doi: 10.1002/14651858.CD003934.pub3.

  PMID: 23959763 BACKGROUND

• Nieuwenhuijze MJ, de Jonge A, Korstjens I, Bude L, Lagro-Janssen TL. Influence on birthing positions affects women's sense of control in second stage of labour. Midwifery. 2013 Nov;29(11):e107-14. doi: 10.1016/j.midw.2012.12.007. Epub 2013 Feb 15.

  PMID: 23415350 BACKGROUND

Study Officials

• Irene Hösli, Prof. Dr. MD

  Chief Physician Departement of Obstetrics and Antenatal care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The medical device will be used according to its market authorization, i.e. CE-Certification. Because it will be used for the first time in pregnant women, a vulnerable population, the following three step application procedure has been determined: * First five pregnant women use the device for 10 minutes. Each of them in a position and module proposed by the midwife with the agreement of the woman. * Next 10 pregnant women use the device for 20 minutes. Again, position and module according to the decision of the midwife in agreement with the woman. * All the remaining pregnant women (35) use the device for 30 minutes. Position and module proposed by the midwife with the agreement of the woman. During the intervention period, position and module might be changed once if required. There will be a safety review board meeting after each group of the pregnant women having used the device, checking the safety criteria according to predefined Adverse Device Effects and Adverse Events.

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: February 23, 2018
• Study Start: January 23, 2018
• Primary Completion: November 6, 2018
• Study Completion: November 6, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)